testing, validation and routine control in …€¦ · testing, validation and routine control in...
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Testing, Validation and Routine
Control in Processing of flexible
Endoscopes in Austria
11. Congresso nazionale AIOS
Lecce 2010
G. Palmisano gespag_center_for_hygiene
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The Problem
• Processing
• thermolabile
• stressed by use and
processing
• high bioburden
• long, narrow lumina
• hardly accessible parts
• poor (no) possibilities for
visual control of
cleanliness
• Practice
• as many examinations as
possible
• in as less time as
possible
• with as few instruments
as possible
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Bioburden of flexible Endoscopes
• After examination:
Up to 1010 cfu / channel• After processing:
< 10 cfu / channel
• RF > 9 log (full cycle)
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Categorisation of Medical Products into Risk
Groups following RKI
Uncritical(contact with intact skin only)
Semicritical(contact with mucosa or
pathological modified skin)
Critical(penetration of skin or
mucosa)
A (without special requirements)(simple construction, no cavities
B (elevated requirements)complex construction, cavities
Asimple construction, no cavities
Bcomplex construction, cavities
C (especially high requirements)like critical B, additionally no
steam sterilisation possible
requirements on reprocessing
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Situation in Austria
• About 470.000 Gastro- and Colonoscopies /
Year
• Hospitals: Processing exclusively in WDs
• Resident doctors: only about 30% automatic
processing
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Annex 2: AEMP (PUMP)-Categorisation
AEMP-Catagory I II III
MP to be processed
Uncritical, semicritical A,
critical A,
hand- and angle pieces
Uncritical,
semicritical A, B,
critical A
all risk groups
QM Adequate Q-AssuranceQM acc. to ONR 112069
and RKI resp.
QM-System according to
EN ISO 13485
Edificial Requirements
Seperate area/
preferable seperation of
zones in
unclean/clean/sterile
seperate processing
room /
seperation of zones in
unclean/clean/sterile
Seperate premises
Seperation of
unclean/clean/sterile
rooms
Qualification of the Staff
Director and agency:
Q-course 1
Staff : Q-course 1
Director and agency:
Q-course 2
Staff : Q-course 1
Director and agency:
Q-course 3
Staff : Q-course 1
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PUMP II
• Seperate Room
• Seperation of
Zones
• „One way“
• WD
• Steriliser acc. to
EN 13060
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EN ISO 15883 Part 1-5: Washer Disinfectors
• Part 1: General Requirements, Definitions and
Tests
• Part 4: Requirements and Tests for WDs for
flexible Endoscopes (WD-E): August 2008
• Part 5: Test Methods (in Revision)
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Testing, Validation and
Routine Control
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OEGSV Guideline for Testing,
Validation and Control of
automatic Cleaning and
Disinfection Procedures of
flexible Endoscopes in accordance with EN ISO 15883- 1, -4 and
CEN ISO/TS 15883-5
(October 2008)
www.oegsv.com
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WD-flexible Endoscopes
• Program Sequence
• Pre Rinsing
• Cleaning
• Intermediate Rinsing
• Disinfection (Glutaraldehyde, Peracetic acid)
• Final Rinsing
• Drying (Purging)
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Type/Works Test (Manufacturer)
• Type test:
• Series of tests to be
carried out with every new
type of WD-E
• should be demanded before
purchase
• Works test:
• Series of tests to be
carried out before
distribution of a machine
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Validation
• Shall ascertain the accordance of the
process to the specifications as well as the
adequacy of the procedure for the
processing of the used MPs
• EN ISO 15883: Validation = Complete
program consisting of
• Installation Qualification,
• Operational Qualification and
• Performance Qualification
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IQ /OQ
• IQ:
• Control, if the WD is
delivered according to
tendering, that it is
supplied with the required
recources and safe for
use
• OQ:
• technical approvement
(in combination with IQ)
• hygienic approvement
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Commissioning
Control of:
• Constructural requirements (PUMP-Concept)
• Technical reuirements (WD + accessories)
• Supply of recources (z.B. deionised water)
• Qualification of director and staff
• Quality assurance and
• In case of first validation of processes in an
already operated WD: OQ
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The „Heart of Validation“: Hygienic Approvement
• Cleaning efficacy
• Chamber, load carrier
• Channels
• Disinfection efficacy
(total germ reduction)
• Channells
• Outer surfaces:
Bioindicators
• Temperature regulation
• thermoelectric
measurements
• Accuracy of display /
printout
• Dosing accuracy
• Water quality
• softened water
• deionised water
• last rinse water
• chemical-physical
• bacteriological
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• Test pieces:• Teflon tubes of 3,5 m
lenght, Inner diameter 1, 2and 4 mm
• simulating the endoscopechannels
• Test soil:• cleaning indicators
• Testing:• Connection to nozzles
• Interruption of theprogrammebefore disinfection
• Acceptance criteria:• No visible residues
Cleaning efficacy „Dummy-Test“
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Testing of „Total Bacterial Reduction“
• Microbiological Test:
• Use of Endoscope dummies
and bio indicators
• Test organism:
• Enterococcus faecium
(ATCC 6057), Initial
bacterial count ~ 1010 cfu/ml
• Testing:
• Full cycle (interruption
before drying)
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• Analysis:• Transfer of bio indicators to solution
with neutralizers for disinfectingagents
• Membranfiltration and plating filters onagar plates
• Calculation of reduction factors:• RF (log) = log cfu control - log cfu test
pieces
• Acceptance criteria:• Total RF > 9
Testing of „Total Bacterial Reduction“ (2)
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Additional tests
• Cleaning/disinfection of outersurfaces: Bioindicators
• Thermoelectric control ofprocess parameters
• Control of dosing
• Physical and bacteriologicalanalysis of the last rinse water
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Performance Qualification
• Tests on real endocopes
• Rinsing of channels
• Bacteriological analysis: AC < 10 cfu/ml
• Protein detection of outer surfaces
(hardly accessible spots) and biopsy
channel with swabs
• AC Outer surface: < 20 g/ instrument
• AC Biopsy channel: < 100 g/ channel
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Routine control (in the course of validation)
• Each lot• Visual control for cleanliness
• Control of programme parameters
• Weekly tests• Tests for protein residuals
(in implementation)
• Use of cleaning indicators
• Conductivity of deionised water(if applicable)
• Quarterly (at least yearly)• Bacteriological tests on rinsing fluids of
channels and last rinse water
Polisaccarido
Sangue
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Routine control (actual situation)
Each used endoscope should be tested
once a year!
• Sampling (hand disinfection, non touch technique!)
• Rinsing fluid: sterile physiological NaCl-solution
• 20 ml per channel, drawn in sterile tubes
• Biopsy channel: to be rinsed by sterile syringe
• Air/water channel: to be rinsed by use of „water bottle“
• Additional channels (Bowden control, Jet channel etc.)
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• Sampling• Swabs from critical spots
(e.g. Albarran lever)
• Last rinse water(e.g. hygiene programme – not to beused in routine!)
• Processing after sampling(evtl. only rinsing and drying)
• Rapid transport to thebacteriological laboratory
Routine control (actual situation) (2)
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Acceptance criteria / Actions to be taken
• Total bacterial count < 10cfu / ml
• E. coli, Enterococci,Enterobacteria: notdetectable• poor cleaning /
disinfection
• P. aeruginosa,Pseudomonas sp.: notdetectable• poor rinsing / drying
• Other relevant pathogens(e.g. S. aureus): notdetectable• poor storage conditions /
hand hygiene
• Testing of WD-E(cleaning/disinfectionefficacy, dosing etc.)
• Testing of water supplyquality (e.g. deionisedwater) / drying /storage
• Instruction of staff /checking storageconditions
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Cleaning indicators
Can be used as part of validation
Recommended as routine control
Do not replace validation of the process
Do not replace periodic testing of the WD
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Summary
• MD Act: Validation is essential
• Ordinance under §94 MDA: coming soon
• OEGSV-guideline for validation of endoscope
reprocessing
• EN ISO 15883 part 4
• That means: Working on Preparation for validation
• Implementation of adequate QM-System (work instructions
etc.)
• Upgrading or new acquisition of WD-E
• Implementing routine controls
• Qualification of the staff
• Documentation etc.
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www.oegsv.com/guidelines
• Risk categorisation of MD
• Guideline for the Validation of CD
Processes
• Annex 3: Aquisition of WDs
• Guideline for the Validation of CD
Processes for flexible Endoscopes
• Obligatory intermediate rinsing for WD-E
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Where is the real problem ?
„..the endoscopist tends to see the hole of the
patient but not the whole patient…and tends to
see the whole instrument ..but not the hole in the
instrument…“
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fine